Apparatus and method for determining the relative position and orientation of neurostimulation leads

ABSTRACT

A method for determining whether the relative position of electrodes used by a neurostimulation system has changed within a patient comprises determining the amplitude of a field potential at each of at least one of the electrodes, determining if a change in each of the determined electric field amplitudes has occurred, and analyzing the change in each of the determined electric field amplitudes to determine whether a change in the relative position of the electrodes has occurred. Another method comprises measuring a first monopolar impedance between a first electrode and a reference electrode, measuring a second monopolar impedance between second electrode and the reference electrode, measuring a bipolar impedance between the first and second electrodes, and estimating an amplitude of a field potential at the second electrode based on the first and second monopolar impedances and the bipolar impedance.

RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. applicationSer. No. 11/343,007, filed Jan. 30, 2006, which is a continuation ofU.S. application Ser. No. 10/310,202, filed Dec. 3, 2002 (now U.S. Pat.No. 6,993,384), which application claims the benefit of U.S. ProvisionalApplication Ser. No. 60/338,331, filed Dec. 4, 2001, each of which isincorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to neurostimulation systems, such as aspinal cord stimulation (SCS) system, and more particularly to a methodfor determining the relative position and orientation of electrodes on aneurostimulation lead or leads used with such a system.

In SCS systems, positioning of the leads is critical to the success ofthe therapy. During surgery, the physician places the leads in a verycareful manner in order to locate the electrodes proximal to neuralelements that are the target of the stimulation. During and afterplacement, stimulation energy is delivered to verify that the leads areindeed stimulating the appropriate neural elements.

However, if the leads happen to shift position, the targeted neuralelements may no longer be appropriately stimulated. At best, this canrequire electrical reprogramming to restore therapy or, at worst,surgical revision, where a second surgery is required and the leads mustbe manually readjusted. In the first case, the physician may have only asuspicion that a lead has shifted position, based on patient reportingof paresthesia, which is not foolproof. Also, attempting to reprogramthe leads based on paresthesia locations can be challenging.

What is needed is a more objective technique for verifying the positionof the leads.

Prior art approaches for determining the lead position are disclosed inU.S. Pat. Nos. 4,486,835; 4,539,640; and 5,184,624, which patents areincorporated herein by reference.

SUMMARY OF THE INVENTION

The present invention addresses the above and other needs by providing across-check technique for verifying the position of the electrodes ofthe implanted leads. A first technique involves the use ofinterelectrode impedance. A second technique involves measured fieldpotentials. A third technique involves estimated field potentials. Anyof these techniques advantageously allows the relative orientation ofone electrode on an implanted lead to other electrodes on the implantedlead or adjacent implanted leads in the spinal column or otherbody/tissue location to be readily determined. Such techniques areuseful not only for reprogramming, but also to estimate if the shiftedorientation of the electrodes is sufficiently large so as to makeelectrical reprogramming a waste of time, thereby suggesting thatsurgery may need to be performed for repositioning.

At present, the correct lead position may only be determined by X-ray orfluoroscopy. Disadvantageously, X-ray and fluoroscopy require expensiveequipment, significant time, and appropriate medical facilities, most ofwhich are not readily available. The general process for fitting aneurostimulation patient, i.e., a spinal cord stimulation patient, isdescribed, e.g., in U.S. Pat. Nos. 6,052,624; 6,393,325; in publishedinternational patent application WO 02/09808 A1 (published 7 Feb. 2002);and in U.S. patent applications (assigned to the same assignee as thepresent application) Ser. No. 09/626,010, filed Jul. 26, 2000; and Ser.No. 09/740,339, filed Dec. 18, 2000, which patents, publication, andapplications are incorporated herein by reference.

As indicated in those documents, prior to fitting a patient with thecertain types of neurostimulation leads, the relative orientation of theelectrodes on the implanted leads should be known in order to allowappropriate navigation of the stimulation energy. At present, adetermination of the relative orientation typically requires that afluoroscope or X-ray image of the implanted leads be present at the timeof patient setup with the system programmer. Disadvantageously, however,such images may not always be available. Moreover, between the time ofimplant and follow-up visits, the leads may have shifted and thefluoroscope image may no longer be valid. This can result in poorpatient outcomes due to inappropriate or unexpected stimulation effectsduring fitting.

Hence, it is seen that there is a need for the cross-check techniquesprovided by the present invention, which techniques can be used toverify the position of the leads at numerous times during the lifetimeof the implanted leads, e.g., during initial implantation andprogramming, during follow-up visits, throughout the trial period, andduring subsequent reprogramming sessions.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.

Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 illustrates a neurostimulation system wherein two leads, eachhaving eight in-line electrodes thereon, are positioned side-by-side,and wherein each lead is connected to an implantable pulse generator(IPG), which IPG is, in turn, coupled to an external programmer;

FIG. 2 shows a functional block diagram of an IPG that uses multipleprogrammable current sources to activate selected electrodes of theneurostimulation leads;

FIG. 3 shows a functional block diagram of an IPG that uses multipleprogrammable voltage sources to activate selected electrodes of theneurostimulation leads;

FIG. 4 is a table that contains impedance vector and distance impedancedata in accordance with one embodiment of the invention;

FIG. 5 illustrates representative relative electrode orientation in apatient having dual quadrapolar leads (two side-by-side leads, eachhaving four in-line electrodes thereon);

FIG. 6 is an impedance map that illustrates application of oneembodiment of he invention to the electrode orientation shown in FIG. 5;

FIG. 7 depicts a representative fluoroscopic image of dual quadrapolarleads in a patient;

FIG. 8 illustrates, in accordance with another embodiment of theinvention, the measured electrode potential of non-activated electrodeson the dual quadrapolar lead of FIG. 7 when the activated electrode isactivated through monopolar stimulation;

FIG. 9 illustrates the measured electrode potential of non-activatedelectrodes on the dual quadrapolar lead of FIG. 7 when the activatedelectrodes are activated through tripolar stimulation;

FIG. 10 illustrates an arrangement of two electrodes and a returnelectrode, wherein monopolar impedance measurements are taken betweenthe two electrodes and the return electrodes, and a bipolar impedancemeasurement is taken between the two electrodes;

FIG. 11 is a field potential matrix created when the two electrodes ofFIG. 10 are sourcing current while field potentials are measured on thetwo electrodes;

FIG. 12 is afield potential matrix created when the three electrodes aresourcing current while field potentials are measured on the threeelectrodes;

FIGS. 13A-13P illustrate a comparison between the actual measured fieldpotential on leads of FIG. 1 and the estimated field potential on theleads of FIG. 1; and

FIG. 14 is a flowchart that highlights the main steps used with oneembodiment of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

At the outset, it is noted that the present invention may be used withan implantable pulse generator (IPG), radio frequency (RF) transmitter,or similar electrical stimulator, that may be used as a component ofnumerous different types of stimulation systems. The description thatfollows relates to a spinal cord stimulation (SCS) system. However, itis to be understood that while the invention lends itself well toapplications in SCS, the invention, in its broadest aspects, may not beso limited. Rather, the invention may be used with any type ofimplantable electrical circuitry used to stimulate tissue. For example,the present invention ma be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical stimulator,a deep brain stimulator, a peripheral nerve stimulator, or in any otherneural stimulator configured to treat urinary incontinence, sleep apnea,shoulder sublaxation, etc.

The embodiments described herein use: (1) interelectrode impedance; (2)actual field potentials; or (3) estimated field potentials to determinethe relative orientation of one electrode on an implanted lead to otherelectrodes on the implanted lead or adjacent implanted leads in thespinal column or other body/tissue location.

Before describing the three techniques, any of which may be used, itwill be helpful to first briefly provide an overview of a representativeneurostimulation system of the type in which these techniques may beused. A representative neurostimulation system is illustrated in FIG. 1.Such system may include a first implantable lead 20 and a secondimplantable lead 30. Each lead includes a series of in-line electrodesthereon. For the example shown in FIG. 1, the first lead 20 containseight in-line electrodes E1, E2, E3, . . . E8. The second lead 30 alsocontains eight in-line electrodes E9, E10, E11, . . . E16.

Each of the electrodes of each lead 20 or 30 are electrically connectedthrough respective wires, embedded or carried within a body of the lead,to an implantable pulse generator (IPG) 40. The wires connected to theelectrodes E1, E2, E3, . . . E8 of lead 20, for example, may becharacterized as a bundle of wires 22 that are electrically connectedwith the IPG 40. Similarly, the wires connected to the electrodes E9,E10, E11, . . . E16 of lead 30 may be characterized as a bundle of wires32 that are electrically connected with the IPG 40. Through these wires,carried within the respective leads 20 or 30, the IPG is able to directelectrical stimulation to selected electrodes of each lead.

When a given electrode is selected to receive an electrical stimulus, itis (for purposes of the present invention) said to be “activated”. Whenan electrode is not selected to receive an electrical stimulus, it issaid to be “non-activated”. Electrical stimulation must always occurbetween two or more electrodes (so that the electrical currentassociated with the stimulus has a path from the IPG to the tissue to bestimulated, and a return path from the tissue to the IPG). The case ofthe IPG may function, in some modes of operation, as a return electrodeE_(R). Monopolar stimulation occurs when a selected one or more of theelectrodes of one of the leads 20 or 30 is activated with a commonpolarity (anode or cathode), and the return electrode E_(R) is activatedat the opposite polarity. Bipolar stimulation occurs when two of theelectrodes of the leads 20 or 30 are activated, e.g., when electrode E3of lead 20 is activated as an anode at the same time that electrode E11of lead 30 is activated as a cathode. Tripolar stimulation occurs whenthree of the electrodes of the leads 20 or 30 are activated, e.g., whenelectrodes E4 and E5 of lead 20 are activated as an anode at he sametime that electrode E13 of lead 30 is activated as a cathode. Ingeneral, multipolar stimulation occurs when multiple electrodes of theleads 20 or 30 are activated, but the IPG case is not used as a returnelectrode.

The IPG 40 is typically programmed, or controlled, through the use of anexternal (non-implanted) programmer 60. The external programmer 60 iscoupled to the IPG 40 through a suitable communications link,represented in FIG. 1 by the wavy arrow 50. Such link 50 passes throughthe skin 18 of the patient. Representative links that may be used tocouple the programmer 60 with the IPG 40 include a radio frequency (RF)link, an inductive link, an optical link, or a magnetic link. Theprogrammer 60, or other similar external device, may also be used tocouple power into the IPG for the purpose of operating the IPG orcharging a replenishable power source, e.g., a rechargeable battery,within the IPG. Once the IPG 40 has been programmed, and its powersource has been fully charged or replenished, it may operate asprogrammed without the need for the external programmer 60 to bepresent.

Turning next to FIG. 2, there is shown a representative functional blockdiagram of one type of IPG 40 that may be used with a neurostimulationsystem. As seen in FIG. 2, the IPG 40 therein depicted is made up of amultiplicity of dual current sources 42. Each dual current source 42includes a positive current source, i.e., a current source that canfunction as an anode to “source” current to a load, and a current sourcethat can function as a cathode to “sink” current from a load through thesame node. The “load” is the tissue that resides between the two or moreactivated electrodes, and includes the wire (or other conductiveelement) and a coupling capacitor C that connects the electrode to thecommon node of the dual current source.

Thus, for example, and as depicted in FIG. 2, a first dual currentsource connected to electrode E1 of a first lead through a couplingcapacitor C, may be programmed to produce a current of +I1 or −I1through electrode E1 depending upon whether such dual current source isconfigured to operate as a cathode or an anode, when such first dualcurrent source is turned on or enabled. Similarly, a second currentsource, connected to electrode E2, when turned on or enabled, may beprogrammed to produce a current of +I2 or −I2 through electrode E2. In asimilar manner, a third current source, when enabled, may be programmedto produce a current of +I3 or −I3 through electrode E3. An nth currentsource, where n represents the number of electrodes on the first lead,is similarly connected to electrode En, and may be programmed to producea current of +In or −In through electrode En when turned on or enabled.

If a second lead, also having n electrodes, is positioned adjacent thefirst lead, each electrode is similarly connected to a dual currentsource. For example, electrode E(n+1) is connected to a dual currentsource that produces a current of +I(n+1) or −I(n+1) through electrodeE(n+1) when such (n+1)th current source is enabled. In like manner, allof the electrodes of the second lead are connected to respective dualcurrent sources. There are thus 2n dual current sources that arerespectively connected to each of the 2n electrodes of the first andsecond leads (n electrodes on each lead). Alternative embodiments (notshown) may employ less than 2n dual current sources connected to 2nelectrodes through a suitable multiplexer circuit.

A programmable current control circuit 44 is also provided within theIPG 40 that controls, i.e., turns on or enables, at specified times, aselected current source to operate as either a cathode or an anode tosource or sink a current having a desired amplitude. The control circuit44 also disables, or turns off, selected current sources, as controlledby programmed control data received from the external programmer, orotherwise resident within the IPG. The control circuit 44 furtherincludes the ability to measure the electrode voltage, E_(V1), E_(V2),E_(V3), . . . E_(Vn), . . . E_(V(2n)), appearing at the output of eachdual current source 42, whether the electrode is activated ornon-activated. This effectively allows the electrode voltage, orelectric field at the electrode, to be measured, which in turnfacilitates impedance or field potential measurements to be made, whichmeasurements are used in carrying out various steps of the invention asdescribed below.

Thus, in operation, and as illustrated in FIG. 2, current controlcircuit 44 may turn on current sources +I1 and +I2 at the same time,i.e., during a time period T1, that current source −I(n+2) is turned on.All other current sources are turned off, or disabled, during the timeT1. Such action causes electrodes E1 and E2 to be activated as anodes atthe same time that electrode E(n+2) is activated as a cathode. That is,a current +I1 is “sourced” from electrode E1 and a current +I2 is“sourced” from electrode E2 at the same time that a current −I(n+2) is“sunk” into electrode E(n+2). The amplitudes of the currents +I1 and +I2may be any programmed values, and the amplitude of the current −I(n+2)should be equal to −(I1+I2). That is, the current that is sourced isequal to the current that is sunk.

After the time period T1, it is common to switch the polarities of theelectrodes during a second-time period T2. During T2, the electrodes E1and E2 are activated as cathodes, so that they both sink current, andelectrode E(n+2) is activated as an anode, so that it sources a currentequal in amplitude to the current that is sunk by electrodes E1 and E2.In this manner, a biphasic stimulation pulse 46 is produced that ischaracterized by a first pulse (during time period T1) of one polarity,followed by a second pulse immediately or shortly thereafter (duringtime period T2) of the opposite polarity. The electrical chargeassociated with the first pulse is made so that it is equal to thecharge associated with the second pulse, thereby maintaining chargebalance during the stimulation. Maintaining charge balance whenstimulating living tissue is generally considered an important componentof a stimulation regime. Charge balance is commonly achieved in abiphasic pulse 46 by making the amplitude of the first pulse during timeT1 equal to the amplitude of the second pulse during time period 12,where T1 equals T2. However, charge balance may also be achieved usingother combinations of pulse duration and amplitude, e.g., by making theamplitude of the second pulse equal to ½ the amplitude of the firstpulse, while making the time period T2 equal to twice the time periodT1.

Next, with respect to FIG. 3, a functional block diagram of another typeof IPG 40′ that may be used in a neurostimulation system is shown. TheIPG 40′ shown in FIG. 3, includes a multiplicity of dual voltage sources42′, each being connected to one of the electrodes E1, E2, E3, . . . En,of a first lead, or to one of the electrodes E(n+1), E(n+2), . . .E(2n), of a second lead. Each dual voltage source 42′ applies aprogrammed voltage, of one polarity or another, to its respectiveelectrode, when enabled or turned on. For the configuration shown inFIG. 3, a separate dual voltage source 42′ is connected to eachelectrode node through a coupling capacitor C. Other embodiments, notshown, may use one or two or ore voltage sources that are selectivelyconnected to each electrode node through a multiplexer circuit.

The control circuit 44′, or other circuitry within the IPG 40′, furtherincludes the ability to measure the electrode current, E_(I1), E_(I2),E_(I3), . . . E_(In), . . . E_(I(2n)), flowing to or from its respectiveelectrode, whether the electrode is activated or non-activated, and theelectrode voltage, E_(V1), E_(V2), E_(V3), . . . E_(Vn), . . .E_(V(2n)), appearing at the output of each non-activated dual voltagesource 42′. These measurements facilitate impedance and electric fieldmeasurements or calculations to be made, which measurements are used incarrying out various steps of the invention as described below.

A programmable voltage control circuit 44′ controls each of the dualvoltage sources 42′, specifying the amplitude, polarity, and duration ofthe voltage that is applied to its respective terminal. Typically,stimulation is achieved by applying a biphasic stimulation pulse 46′ tothe selected electrodes, wherein a voltage of a first polarity andamplitude is applied during time period T3, followed by a voltage of theopposite polarity and amplitude during time period T4. The biphasicstimulation pulse 46′ may be applied between any two or more electrodes.

It should be noted that the functional block diagrams of FIGS. 2 and 3are functional diagrams only, and are not intended to be limiting. Thoseof skill in the art, given the descriptions presented herein, should beable to readily fashion numerous types of IPG circuits, or equivalentcircuits, that carry out the functions indicated and described, whichfunctions include not only producing a stimulus current or voltage onselected groups of electrodes, but also the ability to measure thevoltage, or the current, flowing through an activated or non-activatedelectrode. Such measurements allow impedance to be determined (used witha first embodiment of the invention), allow field potentials to bemeasured (used with a second embodiment of the invention), or allowfield potentials to be estimated (used with a third embodiment of theinvention), as described in more detail below. A preferred IPG isdescribed in international patent application WO 02/09808 A1 (published7 Feb. 2002); and in U.S. patent application Ser. No. 09/626,010, filedJul. 26, 2000, which publication and application have been previouslyreferenced and are incorporated herein by reference.

With the descriptions of FIGS. 1-3 thus providing background informationrelative to a neurostimulation system, the embodiments will next bedescribed. As has been indicated, the embodiments address the problem ofdetermining the relative position between electrodes once the leads onwhich the electrodes are carried have been implanted. The embodimentsuse: (1) interelectrode impedances; (2) actual field potentials; or (3)estimated field potentials to determine the relative orientation of oneelectrode on an implanted lead to other electrodes on the implanted leador adjacent implanted leads in the spinal column or other body/tissuelocation.

First, the interelectrode impedance technique for determining relativeelectrode positions for multipolar leads of a neurostimulation systemwill be explained in connection with FIGS. 4-6. The interelectrodeimpedance technique is performed by measuring impedance vectors. Avector is defined as an impedance value measured between two electrodesin the body. The value of the impedance vector is due primarily to twophysical entities: (1) the electrode-electrolyte interface; and (2) thebulk impedance between the electrodes. The impedance tomographytechnique of the present invention relies upon the latter of the abovetwo physical entities, i.e., upon the bulk impedance between theelectrodes. The bulk impedance portion of the impedance vector may befurther broken up into two contributing factors: (a) the impedance ofthe tissue adjacent to the electrodes; and (b) the impedance of thetissue between the electrodes.

The first factor (part a) makes up the majority of the measurement, dueto the higher and non-uniform current densities near the electrodesurface. However, the second factor (part b), where the current densityis more uniform, has a roughly linear relationship to distance betweenthe two electrodes, due to the definition of resistance. Resistance. R,is defined as R=(resistivity)x(distance)/cross-sectional area. Thesecond factor (part b) is used by the interelectrode impedance techniqueembodiment of the invention to determine the relative spacing betweenelectrodes and to determine the relative orientation of the leads.

By way of example, one first-order, simple embodiment of the inventionis as follows: if two multipolar leads are placed in the spinal column,see FIG. 5, each having four electrodes (the electrodes of one leadbeing designated as e1, e2, e3, and e4; and the electrodes of the otherlead being designated as E5, E6, E7 and E8), their relative orientationmay be inferred by making the following measurements: (1) monopolarimpedances for all electrodes; and (2) bipolar impedances between agiven electrode and each electrode (one at a time) on opposing leads.

The monopolar impedances are used to “correct” the bipolar impedancesfor the first factor of bulk impedance, the strongly-weighted impedancenear the electrode. The corrected bipolar impedances are then used todevelop an impedance “map” between the electrodes. This map reveals therelative orientation of the leads. To illustrate, a sample correctionformula is as follows: (distance between two electrodes e1 &e2)≈(measured bipolar impedance between two electrodes e1 &e2)+(2*offset)−(monopolar Z for electrode e1)−(monopolar Z for electrodee2), where offset=an estimate of the impedance in the monopolarimpedance measurement that is NOT due to the tissue near the electrode.

After the bipolar impedances are corrected by the above formula, therelative orientation of the leads may be inferred by the relative minimaof the impedance values. Where the corrected bipolar impedance betweentwo electrodes is a minimum relative to other electrodes on an opposingarray, those electrodes are relatively adjacent. This information maythen be loaded into a programmer, which can then provide a graphicdisplay of the assumed relative lead positions. Such data and/or displaymight then be compared with previously measured or entered and storedgraphics, indicating earlier orientations. Such comparison can thus helpthe physician/clinician to track the lead orientation to determineappropriate programming, reprogramming, or need for surgical revision.Also, for some programming systems, the present invention may be used toautomatically setup the appropriate navigation tables for steeringmultiple lead systems.

FIG. 4 illustrates data showing this simple embodiment applied to datafrom a patient with dual quadrapolar leads, which leads are oriented asdepicted in FIG. 5. FIG. 6 shows the impedance map resulting from themeasurements of FIG. 4. It can be seen that the impedance maps (FIG. 6)correlate well to the orientation of the leads (FIG. 5).

The simple interelectrode impedance technique described above may beenhanced by making more accurate corrections using the appropriate fieldequations to calculate the monopolar and bipolar impedance of theelectrodes. Also, other geometric methods may be employed using theimproved “distance impedance” values to improve the mapping of theelectrode orientations.

Next, the actual field measurement technique for determining relativeelectrode positions for multipolar leads of a neurostimulation systemwill be explained in connection with FIGS. 7-9. Such a techniqueutilizes field potential measurements of the implanted electrodes, andmore particularly, field potential measurements on non-active electrodescaused by activation of other electrodes. In a preferred embodiment ofthis alternative embodiment, a constant current is sourced (anodes) andsunk (cathodes) from a predefined combination of electrodes. Suchelectrodes thus comprise the activated electrodes. Then, the resultingfield potentials are measured at all other electrodes (those notinvolved in sourcing or sinking current), i.e., the non-activatedelectrodes. From these measured field potentials, the relativeorientation of the electrodes, and the leads on which the electrodes arecarried, may be determined. Advantageously, the use of field potentialsrepresents an improvement over the use of impedance measurements, sincethe measured potential values are less subject to the confoundingeffects of the tissue impedance very close to the source/sinkelectrodes.

By way of example of this field potential measurement technique,consider FIGS. 7, 8 and 9. FIG. 7 represents the relative position ofdual quadrapolar leads 21 and 31 after being implanted in a patient, asobtained using a fluoroscopic imaging device. In many instances, thenecessary imaging equipment needed to obtain a fluoroscopic image, suchas is shown in FIG. 7, is not readily available. Advantageously, thepresent field potential measurement technique represents an alternativeapproach to obtaining relative electrode position information ratherthan using an expensive and cumbersome imaging device.

Two combinations of anodes/cathodes are used to deliver current to theleads of the dual quadrapolar leads 21 and 31. The first technique ismonopolar; that is, current delivered or sourced from one electrode (thecathode) and sunk to the return electrode E_(R) (the anode). Thus, foreach active monopolar combination, there are seven non-active electrodeson which the field potential may be measured. The second technique isflanked tripolar stimulation; that is, current delivered between twoanodes and one cathode, with the cathode being flanked on each side byan anode.

In both the monopolar stimulation and the tripolar stimulation, aconstant current is delivered to each electrode implanted in thepatient's body while the field potential is measured on all otherelectrodes NOT involved in sinking/sourcing current. The constantcurrent may be set to a subperception level, or to another suitablelevel that is comfortable for the patient.

The field potentials for the monopolar stimulation are plotted on thesame chart in FIG. 8. The vertical axis is millivolts. As seen in FIG.8, the electrodes closest to the source electrode have a high fieldpotential (note: all plots in FIG. 8 and FIG. 9 are “negative”, i.e.,more negative potentials results in more positive measured values, asshown in the plots). Thus, for example, consider electrode E8 (curve71), which has its highest field potential relative to electrode E4, andits lowest field potential relative to electrodes E1 and E2, and anintermediate potential relative to electrode E3. This corresponds to theactual electrode positions shown in FIG. 7, where electrode E8 isclosest to electrode E4, somewhat further from electrode E3, andfarthest from electrodes E2 and E1. A similar analysis for the monopolarstimulation fields of the other electrodes reveals a similarrelationship: the electrodes closest to the source electrode have thehigher potential.

The field potentials for the tripolar stimulation are plotted on thesame chart in FIG. 9. Again, the vertical axis is millivolts. As seen inFIG. 9, a better relative orientation can be obtained than can beobtained with the monopolar stimulation. Those electrodes closest to thecathode have a high field potential while those electrodes closest tothe anode have a lower field potential relative to the electrodesfurther away. For example, consider curve 72, which shows the fieldpotential of the non-active electrodes relative to the tripolarstimulation of electrodes E2, E3, E4, with E2 and E4 being anodes, andE3 being a cathode. As seen in FIG. 9, curve 72 has a peak correspondingto electrode E7, which means electrode E7 is closest to the cathode E3.Curve 72 further has lows or valleys corresponding to electrodes E6 andE8, which means E6 and E8 are closest to anode electrodes E2 and E4. Theactual orientation of the electrodes shown in FIG. 7 reveals that E6 isclosest to E2, and E8 is closest to E4. Thus, it is seen that thoseelectrodes closest to the flanked cathodic electrode have a high fieldpotential while those electrodes closest to the anodic electrodes, oneither side of the cathodic electrode, have a lower field potentialrelative to the electrodes further away.

Hence, it is seen that by measuring the field potential of thenon-active electrodes, when active electrodes are stimulated at constantcurrent levels, e.g., subperception levels, the relative orientation ofthe neurostimulation leads may be determined. Once known, the relativeorientation may be used to perform any one or more of a variety ofcorrective actions, as will be described in further detail below.

Next, the estimated field potential technique for determining relativeelectrode positions for multipolar leads of a neurostimulation systemwill be explained in connection with FIGS. 10 and 11. Like the previoustechnique, this technique analyzes the field potentials at the implantedelectrodes. Unlike the previous technique, however, this techniqueestimates the field potentials at the implanted electrodes based onmeasured electrical parameters, and in particular, measured monopolarand bipolar impedances. Notably, this technique has the advantage ofminimizing the number of actual measurements performed by theneurostimulation system in the case where impedance measurements mustalready be taken to effect another function, such as verifying contactcontinuity, remaining battery charge estimation, detecting electrodeshorts, etc. That is, in the previous technique, actual field potentialmeasurements would have to be measured to determine the relativeorientation of the electrodes E1-E16 (shown in FIG. 1) in addition tothe impedance measurements measured to effect a function unrelated tothe relative electrode orientation determination.

As illustrated in FIG. 10, a first monopolar impedance measurement istaken between a first one of the electrodes E1-E16 (in this caseelectrode E1) and the return electrode E_(R), a second monopolarimpedance measurement is taken between a second one of the electrodesE1-E16 (in this case, electrode E2) and the return electrode E_(R), anda bipolar impedance measurement is taken between the first and secondones of the electrodes E1-E16 (in this case, between electrodes E1 andE2). As will be described in further detail below, the field potentialthat would have been created at electrode E2 had electrode E1 beenactivated in a monopolar manner can then be estimated based on theseimpedance measurements. The impedance measurements can be taken in thesame manner described above with respect to the first technique.Notably, the estimate of the field potential at electrode E2 will beapproximately equal to the actual field potential measured at electrodeE2, as an inactive electrode, assuming that electrode E1 would have beenactivated. The monopolar and bipolar impedance measurements can beperformed on each pair of electrodes E1-E16 to obtain field potentialestimations for each electrode (i.e., 15 field potential estimations foreach electrode corresponding to 15 assumed activations of the remainingelectrodes).

Referring now to FIG. 11, the theory behind estimating field potentialsbased on monopolar and bipolar impedance measurements will now beexplained. If electrode E1 sources current in a monopolar fashion toelectrode E_(R), a field potential Φ_(a) is created at electrode E1.Similarly, if electrode E2 sources current in a monopolar fashion toelectrode E_(R), a field potential Φ_(b) is created at electrode E2. Byreciprocity, a field potential Φ_(c) is seen on electrode E1 whenelectrode E2 sources current, and on electrode E2 when electrode E1sources current. Assuming that the field potentials Φ_(a)−Φ_(c), areunknown, linear superposition can be applied to estimate fieldpotentials on electrodes E1, E2 when both are used to source/sinkcurrent simultaneously. Note that the field potential Φ_(a) is equal tothe monopolar impedance of electrode E1 if the source current is unitvalue, and the field potential Φ_(b) is equal to the monopolar impedanceof electrode E2 if the source current is unit value. Solving for bipolarimpedance/field potentials, and letting electrode E1 source unit currentand electrode E2 sink unit current, the bipolar field potential atelectrode E1 will equal the monopolar field potential Φ_(a)−themonopolar field potential Φ_(c), and the bipolar field potential atelectrode E2 will equal the monopolar field potential Φ_(c)−themonopolar field potential Φ_(b). Assuming that the bipolar impedanceR_(bp) between electrodes E1 and E2 equals the voltage potential (ΔV)between electrodes E1 and E2 divided by the unit current (I) betweenelectrodes E1 and E2, thenR_(bp)=((Φ_(a)−Φ_(c))−(Φ_(c)−Φ_(b)))/1=Φ_(a)+Φ_(b)−2Φ_(c). Because themonopolar field potentials Φ_(a) and Φ_(b) at electrodes E1 and E2respectively equal the monopolar impedances R_(mp1) and R_(mp2) atelectrodes E1 and E2, assuming unit current, it follows thatΦ_(c)=−(R_(bp)−R_(mp1)−R_(mp2))/2. Thus, the field potential at anyelectrode due to active passage of current at other electrode(s) can beestimated based on measured monopolar/bipolar impedances by solving forthe electrical voltage potential Φ_(c).

Notably, while this equation has been presented herein to estimate afield potential Φ_(c) for the purpose of determining the migration ofelectrical leads or electrodes, any one of the monopolar impedancesbetween two electrodes and a return electrode, the bipolar impedancebetween the two electrodes, and the field potential at one of the twoelectrodes can be estimated by actually measuring the remaining two ofthe monopolar impedances, bipolar impedance, and field potential tosolve the equation for the estimated parameter. Thus, instead ofmeasuring all three of these parameters, only two of them need to beactually measured, while the remaining parameter can be estimated.

While estimation of field potentials from monopolar and multipolarimpedance measurements (or estimation of a multipolar impedance usingfield potentials and monopolar impedance; or estimation of a monopolarimpedance using field potentials and multipolar impedance) has beenillustrated with a simple two-contact (plus distant return for monopolarmeasurements) system, it is noted that many monopolar and multipolarcombinations with two or more electrodes could be used to estimate fieldpotentials (or impedances) given the linearity and reciprocityassociated with the solution method.

For example, referring now to FIG. 12, if electrode E1 sources currentin a monopolar fashion to electrode E_(R), a field potential Φ_(a) iscreated at electrode E1; if electrode E2 sources current in a monopolarfashion to electrode E_(R), a field potential Φ_(b) is created atelectrode E2; and if electrode E3 sources current in a monopolar fashionto electrode E_(R), a field potential Φ_(c) is created at electrode E3.By reciprocity, a field potential Φ_(d) is seen on electrode E1 whenelectrode E2 sources current, and on electrode E2 when electrode E1sources current; a field potential Φ_(e) is seen on electrode E2 whenelectrode E3 sources current, and on electrode E3 when electrode E2sources current; and a field potential Φ_(f) is seen on electrode E1when electrode E3 sources current, and on electrode E3 when electrode E1sources current.

Assuming that field potentials Φ_(a)−Φ_(f) are initially unknown, theremay be a variety of ways to estimate the field potentials Φ_(a)−Φ_(f)using linear supposition. For example, the field potentials Φ_(a)−Φ_(f)can be estimated by configuring the electrodes E1-E3 in threeconfiguration (1 tripolar configuration, 1 bipolar configuration, and 1monopolar configuration).

Assume for the tripolar configuration that unit values of +0.5, −1.0,and +0.5 are respectively applied to electrodes E1-E3, then therespective monopolar field potentials m1-m3 on electrodes E1-E3 will bewill m1=0.5Φ_(a)+0.5Φ_(f)−Φ_(d); m2=−Φ_(b)+0.5Φ_(e)+0.5Φ_(d); andm3=0.5Φ_(c)0.5Φ_(f)−Φ_(e). Assume for the bipolar configuration thatunit values of +1.0 and −1.0 are respectively applied to electrodes E1and E2, then the respective monopolar field potentials m4 and m5 onelectrodes E1 and E2 will be will m4=−Φ_(a)−Φ_(d); and m5=Φ_(d)−Φ_(b).Assume for the monopolar configuration that a unit value of −1.0 isapplied to electrode E3, then a monopolar field potential m6 onelectrode E3 will be −Φ_(c).

Based on the field potential measurements m1-m6, the six unknown fieldpotentials Φ_(a)−Φ_(f) can be solved using common algebraic techniquesor linear algebraic techniques, as follows:

Φ_(a)=2m1−4m2−2m3+4m5−m6

Φ_(b)=2m1−4m2−2m3−m4+3m5−m6

Φ_(c) =−m6

Φ_(d)=2m1−4m2−2m3−m4+4m4−m6

Φ_(e)=2m1−2m2−2m3−m4+2m4−m6

Φ_(f)=4m1−4m2−2m3−2m4+4m5−m6

The calculated field potentials Φ_(a)−Φ_(f) can be used to estimatebipolar impedances and monopolar impedances and potential differencesfor arbitrary electrode configurations. That is, assuming a unitcurrent, the monopolar impedances on electrodes E1-E3 will be the fieldpotentials Φ_(a)−Φ_(c), and the bipolar impedances on electrodes E1, E2will be Φ_(a)−Φ_(b)−2Φ_(d), bipolar impedances on electrodes E2, E3 willbe Φ_(b)−Φ_(c)−2Φ_(e), and bipolar impedances on electrodes E1, E3 willbe Φ_(a)−Φ_(c)−2Φ_(f).

Referring to FIGS. 13A-13P, it can be seen that the estimated fieldpotential of any electrode calculated in accordance with this equationis approximately the same as the field potential actually measured atthe electrode in response to the monopolar delivery of electricalcurrent from another electrode to the return electrode. In particular,two percutaneous leads carrying eight electrodes (similar to the leads20, 30 shown in FIG. 1) each were introduced into a sausage loaf, whichhas been found to closely simulate the introduction leads into thespinal column of a patient. In each of the cases, current was sourcedfrom a different electrode in a monopolar manner and actual fieldpotentials were measured on each of the other electrodes. In each of thecases, a monopolar impedance was also measured at a different electrode,bipolar impedances were measured between the different electrode and theother electrodes, and field potentials were estimated for the otherelectrodes.

For each case, the actual and estimated field potentials were thenplotted together, as shown in FIGS. 13A-13P. The vertical axisrepresents millivolts (in response to a 1 mA current sink), and thehorizontal axis represents the electrode designation (m1-m18). Theelectrode having the highest field potential will be the closestelectrode to the electrode that is currently sourcing the current (inthe case where actual field potentials are measured) or the closestelectrode to the electrode at which the monopolar and bipolar impedancesare measured (in the case where the field potentials are estimated. Moresignificant to the determination of the relative positions of the leadscarrying the electrodes, the electrode having the highest fieldpotential on one lead will typically be the closest electrode to theelectrode that is sinking the monopolar current from the other lead orthe closest electrode to the electrode at which the monopolar andbipolar impedances are measured. For example, referring to FIG. 13A,electrode E9 has the highest potential of the electrodes on the secondlead relative to the electrode E1 on the first lead, and thus, isclosest in proximity to the electrode E1.

Next, with reference to FIG. 14, a flowchart is shown that illustratesthe main steps that may be used to carry out and apply the techniquesdescribed above. First, the amplitudes of the pertinent electricalparameters are acquired at the electrodes (block 82). For example, ifthe interelectrode impedance measurement technique is used, thepertinent electrical parameters will be impedance vectors, as describedabove with respect to FIGS. 4-7. If the field potential measurementtechnique is used, the pertinent electrical parameters will be actualfield potentials, as described above with respect to FIGS. 8-9. In thiscase, suitable stimuli, e.g., subperception stimuli, are applied todifferent electrodes as activated electrodes. While the stimulus isbeing applied to each of the activated electrodes, field potentials atthe non-activated electrodes are measured. If the field potentialestimation technique is used, the electrical parameter will be anestimated field potential, as described above with respect to FIG.10-12. In this case, the monopolar impedances between the electrodes andthe return electrode are measured, the bipolar impedances between theelectrodes are measured, and the field potentials at the electrodes areestimated therefrom.

The amplitudes of the acquired electrical parameters are then saved(block 86), and the stored electrical parameter data is compared topreviously-saved electrical parameter data for the same electrodes(block 88). The previously-saved electrical parameter data may have beenobtained during initial implantation of the leads, or during the lastvisit (several weeks or months ago) to the doctor. Or, thepreviously-saved electrical parameter data may have been obtained just anew hours or minutes ago at a time when the patient's body had assumed adifferent posture position. Regardless of when the previously-savedelectrical parameter data was obtained, the purpose of the comparisonperformed at block 88 is to determine if the relative position of theleads has changed, which change in position would also have caused arelative change in the position of the electrodes carried on the leads.Such determination may be made by analyzing the electrical parameterdata (block 90) as described above in connection with FIGS. 4-7 (wherethe electrical parameter data are impedance vectors), in connection withFIGS. 8-9 (where the electrical parameter data are actual fieldpotentials), or in connection with FIGS. 10-12 (where the electricalparameter data are estimated field potentials), to determine whether therelative electrode orientation has changed.

The magnitude of the difference in the compared electrical parameterdata may advantageously provide a relative measure of how far the leadhas shifted or moved since the last electrical parameter data wasobtained. If a determination has been made that the leads (electrodes)have not shifted relative to each other (block 90), the process returnsto block 84. Advantageously, if a determination has been made that theleads (electrodes) have shifted relative to each other (block 90),appropriate correction action may be taken, as needed (block 92). Thecorrective action taken at block 92 may include, for example, simplytracking the lead migration over time, so that other corrective action,e.g., surgery to reposition the leads, can be taken when necessary. Evenif new surgery to reposition the leads is not needed, simply mapping thelead migration overtime will enable reprogramming of the stimuliparameters as needed so that a desired effect can be obtained regardlessof the lead movement.

The corrective action may further include setting up stimulationconfigurations and parameters for providing nominal stimulation suitablefor the electrodes in their new relative positions. For example, theamplitude of the stimulus applied to one electrode may be decreased ifit is determined that the electrode has migrated closer to anotherstimulating electrode of the same polarity during stimulation, therebypreserving approximately the same stimulation effect for the patient.Alternatively, the amplitude of the stimulus applied to the electrodemay be increased if the electrode has migrated closer to a stimulatingelectrode of the opposite polarity. Such amplitude adjustments may bemade manually or automatically, depending on the mode of operation ofthe neurostimulation system.

Yet another corrective action that may be taken at block 92 is to adjustthe distribution of the stimuli to a new location through navigation.Navigation, as described in the previously referenced patent documents,involves electronically shifting the stimulus current from one group ofelectrodes to another so as to shift or move the location where thepatient feels the most beneficial paresthesia, and/or receives the mostbenefit. Such navigation allows the neurostimulation system to bequickly “fitted” to a given patient. Fitting the neurostimulation systemto the patient is necessary after the system is first implanted, and mayalso be necessary whenever the leads (electrodes) have moved. Theneurostimulation system provides a relatively easy way to determinewhether such lead movement has occurred, and thereby whether a refittingis or may be necessary.

Yet additional corrective action that may be taken at block 92 inresponse to a determination that lead migration or postural changes haveoccurred includes manually or automatically adjusting the stimulationenergy to a previously-defined optimal field potential.

It is thus seen that the present invention uses a measure or estimationof impedance or electric field to determine relative lead positions formultipolar leads in a multi-lead configuration of a neurostimulationsystem, e.g., a spinal cord stimulation system. It is also seen that theneurostimulation system uses impedance or electric field measurements orestimations to determine relative lead positions, which impedance orelectric field measurement estimations may be used as an automated orassistive method for setting up a programmer for navigation, otherprogramming, or diagnostic evaluations in spinal cord (or other neural)stimulation. It is additionally seen that the neurostimulation systemmay be directed to the storing of impedance or electric field maps tochronically track relative lead positions in a programmer linked to adatabase, along with other patient data.

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

1. (canceled)
 2. A system, comprising: an implantable pulse generator; aplurality of electrodes configured to be operably coupled to theimplantable pulse generator, the plurality of electrodes including areturn or reference electrode and further including other electrodes;and a programmable external device configured to program the implantablepulse generator, wherein the system configured to: measure a firstmonopolar electrical impedance between a first one of the otherelectrodes and the return or reference electrode; measure a secondmonopolar electrical impedance between each of the other ones of theother electrodes and the return or reference electrode; measure abipolar electrical impedance between the first one of the otherelectrodes and each of the other ones of the other electrodes; determinethe amplitude of a field potential at each of the other electrodes basedon the measured first monopolar electrical impedance, each of the secondmonopolar electrical impedances, and each of the measured bipolarelectrical impedances; and determine the relative positions of theelectrodes based on each of the determined field potential amplitudes.3. The system of claim 2, further comprising a plurality of leads thatinclude the at least one electrode, wherein the system is configured todetermine the relative positions of the leads based on the determinedfield potential amplitude at each of the at least one electrode.
 4. Thesystem of claim 2, wherein the system is further configured to:determine if a change in each of the determined field potentialamplitudes has occurred; and analyze the change in each of thedetermined field potential amplitudes to determine whether a change inthe relative position of the electrodes has occurred.
 5. The system ofclaim 2, wherein the system is configured to automatically initiatecorrective action when a determination is made that the relativeposition of the electrodes has changed.
 6. The system of claim 5,wherein the system is configured to automatically initiate correctiveaction by adjusting the amplitude of tissue stimulating electricalenergy applied to selected ones of the electrodes.
 7. The system ofclaim 5, wherein the system is configured to automatically initiatecorrective action by changing selected ones of the electrodes throughwhich tissue stimulating electrical energy is applied.
 8. The system ofclaim 2, further comprising a plurality of leads that include the atleast one electrode, wherein the system is configured to: determine if achange in each of the determined field potential amplitudes hasoccurred; and analyze the change in each of the determined fieldpotential amplitudes to determine whether the leads have migratedrelative to each other.
 9. The system of claim 2, wherein the system isconfigured to display the determined relative positions of theelectrodes.
 10. The system of claim 2, wherein the system is configuredto directly measure the field potential amplitude directly at each ofthe at least one electrode to determine the amplitude of the fieldpotential.
 11. The system of claim 2, wherein the system is configuredto determine the amplitude of the field potential by estimating theamplitude of the field potential at each of the at least one electrodein accordance with the equation Φ=(I_(bp)−I_(mp1)−I_(mp2))/2, where Φequals the amplitude of the field potential, I_(bp) equals therespective bipolar electrical impedance, I_(mp1) equals the firstmonopolar electrical impedance, and I_(mp2) equals the respective secondmonopolar electrical impedance.
 12. The system of claim 2, wherein thesystem is configured to store each of the determined field potentialamplitudes.
 13. The system of claim 2, wherein the system is configuredto use the determined relative positions of the electrodes to providetherapy by delivering tissue stimulating electrical energy to selectedones of the electrodes.
 14. A system, comprising: an implantable pulsegenerator; a plurality of electrodes configured to be operably coupledto the implantable pulse generator, the plurality of electrodesincluding a return or reference electrode and further including otherelectrodes; and a programmable external device configured to program theimplantable pulse generator, wherein the system configured to: measure afirst monopolar impedance between a first one of the other electrodesand the return or reference electrode; measure a second monopolarimpedance between a second one of the other electrodes and the return orreference electrode; measure a bipolar impedance between the firstelectrode and the second electrode; and estimate an amplitude of a fieldpotential at the second electrode based on the first and secondmonopolar impedances and the bipolar impedance.
 15. The system of claim14, wherein the system is configured to apply an electrical stimulationbetween the first electrode and the return or reference electrode, andthe estimated field potential amplitude is approximately equal to theactual field potential at the second electrode when the electricalstimulus is conveyed between the first electrode and the return orreference electrode.
 16. The system of claim 14, wherein the system isconfigured to determine whether a change in the relative positions ofthe electrodes has occurred based on the estimated field potentialamplitude.
 17. The system of claim 14, wherein the system is configuredto perform a function based on at least one of the first monopolarimpedance, second monopolar impedance, and bipolar impedance, whereinthe function is one or more of determining a remaining battery life ofthe pulse generator and detecting an electrical short.
 18. The system ofclaim 14, wherein the system is configured to automatically initiatecorrective action when a determination is made that the relativeposition of the electrodes has changed.
 19. The system of claim 14,wherein the system is configured to display the determined relativepositions of the electrodes.
 20. The system of claim 14, wherein thesystem is configured to estimate the amplitude of the field potential inaccordance with the equation Φ=(I_(bp)−I_(mp1)−I_(mp2))/2, where Φequals the magnitude of the field potential, I_(bp) equals the bipolarelectrical impedance, I_(mp1) equals the first monopolar electricalimpedance, and I_(mp2) equals the second monopolar electrical impedance.21. A system, comprising: an implantable pulse generator; a plurality ofelectrodes configured to be operably coupled to the implantable pulsegenerator, the plurality of electrodes including at least one electrodeand further including a return or reference electrode; and aprogrammable external device configured to program the implantable pulsegenerator, wherein the system configured to perform two measurementprocesses selected from the following measurement processes: (1) ameasurement process to measure a first monopolar impedance between afirst one of the electrodes and a return or reference electrode, andmeasure a second monopolar impedance between a second one of theelectrodes and the return or reference electrode; (2) a measurementprocess of a bipolar impedance between the first electrode and thesecond electrode; and (3) a measurement process afield potential at thesecond electrode; and wherein the system is further configured toestimate a remaining one of the (1) first and second monopolarimpedances; (2) the bipolar impedance; and (3) the field potential basedon the performance of the two measurements in accordance with theequation Φ=(I_(bp)−I_(mp1)−I_(mp2))/2, where Φ equals the fieldpotential, I_(bp) equals the bipolar electrical impedance, I_(mp1)equals the first monopolar electrical impedance, and I_(mp2) equals thesecond monopolar electrical impedance.